Fast Freeze

Product NDC
66902-016
11-digit product format
669020016
Labeler code
66902
Product ID
66902-016_23a8b4cf-a5ed-57c9-e063-6394a90a494b
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
GEL
Route
TOPICAL
Labeler
Natural Essentials Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-01-01
Substance
MENTHOL
Active strength
35 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Fast Freeze
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL35 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
808955Internal RxNorm lookup
1365998Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a96e3e41-871c-4cf3-93b6-af2a6246ded8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66902-016-01Fast Freeze1 g in 1 BOTTLE, PUMPGEL14
66902-016-03Fast Freeze1 g in 1 BOTTLEGEL14
66902-016-04Fast Freeze1 g in 1 TUBEGEL14
66902-016-05Fast Freeze1 g in 1 PACKETGEL14
66902-016-16Fast Freeze1 g in 1 BOTTLE, PUMPGEL14
66902-016-32Fast Freeze1 g in 1 BOTTLE, PUMPGEL14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3AFAST FREEZE (MENTHOL) GEL [NATURAL ESSENTIALS INC.]1
MENTHOLACTIVE MOIETYL7T10EIP3AFAST FREEZE (MENTHOL) GEL [NATURAL ESSENTIALS INC.]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0FAST FREEZE (MENTHOL) GEL [NATURAL ESSENTIALS INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XFAST FREEZE (MENTHOL) GEL [NATURAL ESSENTIALS INC.]1
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENT59TL3WG5COFAST FREEZE (MENTHOL) GEL [NATURAL ESSENTIALS INC.]1
ILEX PARAGUARIENSIS LEAFINACTIVE INGREDIENT1Q953B4O4FFAST FREEZE (MENTHOL) GEL [NATURAL ESSENTIALS INC.]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302FAST FREEZE (MENTHOL) GEL [NATURAL ESSENTIALS INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TFAST FREEZE (MENTHOL) GEL [NATURAL ESSENTIALS INC.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKFAST FREEZE (MENTHOL) GEL [NATURAL ESSENTIALS INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RFAST FREEZE (MENTHOL) GEL [NATURAL ESSENTIALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66902-016FAST FREEZE (MENTHOL) GEL [NATURAL ESSENTIALS INC.]4Current NDC, Legacy NDC, 6 package rows20241006_a96e3e41-871c-4cf3-93b6-af2a6246ded8.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 138 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Joint and Muscle PainMENTHOLShaklee Corporation3943824f-1f4f-4d6f-bd73-0b1be02162a52024-01-30WarningsExact identifier
application number: M017
Mirakel Pain Relief Roll-OnLIDOCAINE HCLSanvio, Inc.102f3618-13ad-37e3-e063-6294a90a80862024-01-30WarningsExact identifier
application number: M017
Blistex Lip MedexPETROLATUM, MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC), AND PHENOLBlistex Inc.8ad39005-9419-4f1a-a1ae-2f76d212455e2024-01-26WarningsExact identifier
application number: M017
Point Relief Cold Spot Pain RelievingMENTHOLFabrication Enterprisesad5d6f04-15e6-4548-95c2-32271c186bc12024-01-25WarningsExact identifier
application number: M017
MIND BODY MATRIX PAIN RELIEFMENTHOLFunctional Energetic, Inc.3667dd0d-942e-4101-ba98-cb013ae77cf52024-01-25WarningsExact identifier
application number: M017
SUPER WHITE STUFF Pain ReliefMENTHOLBLUE SPRING WELLNESSe6d27df5-118c-4c6d-86e8-7b4401a39c762024-01-23WarningsExact identifier
application number: M017
Burn First AidBURN FIRST AIDDynarex Corporation826e08be-dffa-5a27-e053-2a91aa0a87012024-01-22WarningsExact identifier
application number: M017
Target Up and Up Pain Relief Menthol Topical Analgesic Roll-OnMENTHOLTARGET CORPORATION0f95fc55-8665-9e89-e063-6394a90a78912024-01-22WarningsExact identifier
application number: M017
CVS Health Lidocaine Pain Relief Plus MentholLIDOCAINE, MENTHOL, UNSPECIFIED FORMNatural Essentials, Inc.77978069-a1b4-473e-83c9-8320e00eea892024-01-19WarningsExact identifier
application number: M017
ZIMS MAX FREEZE LEG CRAMPSCAMPHOR, MENTHOLKOBAYASHI Healthcare International, Inc.ba26635d-95d3-4d88-93cc-1fd4fd29fd792024-01-18WarningsExact identifier
application number: M017
BurnLIDOCAINEHART Healthe95ebdac-9789-41c2-97da-2307e45387942024-01-18WarningsExact identifier
application number: M017
Medi-First Hydrocortisone 1%HYDROCORTISONE ACETATEUnifirst First Aid Corporationbd216f5d-f304-7d8d-e053-2a95a90aa9ce2024-01-17WarningsExact identifier
application number: M017
Green Guard Hydrocortisone 1%HYDROCORTISONEUnifirst First Aid Corporationbd348e2a-57b1-3f17-e053-2a95a90a8bdc2024-01-17WarningsExact identifier
application number: M017
Pain ReliefLIDOCAINE, MENTHOLHUMN Pharmaceuticals Inc6c96f94a-e724-eab3-e053-2991aa0aab882024-01-17WarningsExact identifier
application number: M017
CVS Health Lidocaine Pain ReliefLIDOCAINENatural Essentials, Inc.52e82e70-53b7-4ecb-be39-fe10c94cc4442024-01-17WarningsExact identifier
application number: M017
CVS Health XL Lidocaine Pain ReliefLIDOCAINENATURAL ESSENTIALS, INC.ec16da91-8244-402b-b8d8-84896094ac2c2024-01-17WarningsExact identifier
application number: M017
Anti-itchDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATETarget Corporationf444b0a6-2ed3-4236-8206-3421502906752024-01-17WarningsExact identifier
application number: M017
Maximum Strength Hydrocortisone Anti-itchHYDROCORTISONE 1%Target Corporation4ff39cb8-3a20-4fe7-9829-1e882a4846682024-01-17WarningsExact identifier
application number: M017
Salonpas Pain Relieving LIDOCAINE 4% FLEXLIDOCAINEHisamitsu Pharmaceutical Co., Inc.9507f727-c49f-4de4-9d64-b6d977d568ab2024-01-17WarningsExact identifier
application number: M017
BurnLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.eca272cb-ac8f-982b-e053-2995a90aa8b22024-01-15WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1365998FAST FREEZE 3.5 % Topical GelPSNa96e3e41-871c-4cf3-93b6-af2a6246ded84
808955menthol 3.5 % Topical GelPSNa96e3e41-871c-4cf3-93b6-af2a6246ded84
1365998menthol 0.035 MG/MG Topical Gel [Fast Freeze Naturally Cool]SBDa96e3e41-871c-4cf3-93b6-af2a6246ded84
808955menthol 0.035 MG/MG Topical GelSCDa96e3e41-871c-4cf3-93b6-af2a6246ded84
1365998Fast Freeze Naturally Cool 0.035 MG/MG Topical GelSYa96e3e41-871c-4cf3-93b6-af2a6246ded84
1365998Fast Freeze Naturally Cool 3.5 % Topical GelSYa96e3e41-871c-4cf3-93b6-af2a6246ded84
808955menthol 3.5 % Topical GelSYa96e3e41-871c-4cf3-93b6-af2a6246ded84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66902-016-01669020016011 g in 1 BOTTLE, PUMP (66902-016-01) 1 g2013-01-010000-00-00NoNoCurrent
66902-016-03669020016031 g in 1 BOTTLE (66902-016-03) 1 g2013-01-010000-00-00NoNoCurrent
66902-016-04669020016041 g in 1 TUBE (66902-016-04) 1 g2013-01-010000-00-00NoNoCurrent
66902-016-05669020016051 g in 1 PACKET (66902-016-05) 1 g2013-01-010000-00-00NoNoCurrent
66902-016-16669020016161 g in 1 BOTTLE, PUMP (66902-016-16) 1 g2013-01-010000-00-00NoNoCurrent
66902-016-32669020016321 g in 1 BOTTLE, PUMP (66902-016-32) 1 g2013-01-010000-00-00NoNoCurrent